Alkermes plc (NASDAQ: ALKS) today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). These studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Approximately two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy.
"FORWARD-3 and FORWARD-4 incorporate features from our previous successful studies of ALKS 5461, including state-of-the-art design elements to reduce the impact of placebo response in depression trials," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "With these study initiations, four of the 12 studies from the FORWARD program are now underway since the launch of the pivotal program in March."
FORWARD-3 and FORWARD-4 are both phase 3, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy and safety of ALKS 5461 as adjunctive treatment in patients with MDD. The two studies combined are expected to randomize approximately 1,000 patients and incorporate sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these two core efficacy studies are expected in 2016. FORWARD-5, the third core efficacy trial, is expected to initiate in mid 2014.